Non-compliant medical balloon having a longitudinal fiber layer

ABSTRACT

A non-compliant medical balloon is formed with a first fiber layer including a first fiber and a second fiber layer over said first fiber layer. The first fiber is substantially parallel to a longitudinal axis of the non-compliant medical balloon.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/726,960, filed Dec. 3, 2003 and U.S. patent application Ser. No.10/726,464, filed Dec. 3, 2003.

This application is related to U.S. Pat. No. 6,746,425, issued Jun. 8,2004, which is a continuation-in-part of U.S. patent application Ser.No. 08,873,413, filed Jun. 12, 1997, which claims benefit of U.S.provisional application 60/019,931, filed Jun. 14, 1996.

FIELD OF THE INVENTION

This invention relates to the field of balloons that are useful inangioplasty and other medical uses.

BACKGROUND OF THE INVENTION

Catheters having inflatable balloon attachments have been used forreaching small areas of the body for medical treatments, such as incoronary angioplasty and the like. Balloons are exposed to large amountsof pressure. Additionally, the profile of balloons must be small inorder to be introduced into blood vessels and other small areas of thebody. Therefore, materials with high strength relative to film thicknessare chosen. An example of these materials is PET (polyethyleneterephthalate), which is useful for providing a non-compliant,high-pressure device. Unfortunately, PET and other materials with highstrength-to-film thickness ratios tend to be scratch- andpuncture-sensitive. Polymers that tend to be less sensitive, such aspolyethylene, nylon and urethane are compliant and, at the same filmthickness as the non-compliant PET, do not provide the strength requiredto withstand the pressure used for transit in a blood vessel andexpansion to open an occluded vessel. Non-compliance, or the ability notto expand beyond a predetermined size on pressure and to maintainsubstantially a profile, is a desired characteristic for balloons so asnot to rupture or dissect the vessel as the balloon expands. Furtherdifficulties often arise in guiding a balloon catheter into a desiredlocation in a patient due to the friction between the apparatus and thevessel through which the apparatus passes. The result of this frictionis failure of the balloon due to abrasion and puncture during handlingand use and also from over-inflation.

SUMMARY OF THE INVENTION

The present invention is directed to a non-compliant medical balloonsuitable for angioplasty and other medical procedures and whichintegrally includes very thin inelastic fibers having high tensilestrength, and methods for manufacturing the balloon. The fiberreinforced balloons of the present invention meet the requirements ofmedical balloons by providing superior burst strength; superiorabrasion-, cut- and puncture-resistence; and superior structuralintegrity.

More particularly, the invention is directed to a fiber-reinforcedmedical balloon having a long axis, wherein the balloon comprises aninner polymeric wall capable of sustaining pressure when inflated orexpanded and a fiber/polymeric matrix outer wall surrounding andreinforcing the inner polymeric wall. The fiber/polymeric matrix outerwall is formed from at least two layers of fibers and a polymer layer.The fibers of the first fiber layer are substantially equal in length tothe length of the long axis of the balloon and run along the length ofthe long axis. But “substantially equal in length” is meant that thefiber is at least 75% as long as the length of the long axis of theballoon, and preferably is at least 90% as long. The fiber of the secondfiber layer runs radially around the circumference of the long axis ofthe balloon substantially over the entire length of the long axis. By“substantially over the entire length” is meant that the fiber runsalong at least the center 75% of the length of the long axis of theballoon, and preferably runs along at least 90% of the length. The fiberof the second fiber layer is substantially perpendicular to the fibersof the first fiber layer. By “substantially perpendicular to” is meantthat the fiber of the second fiber layer can be up to about 10 degreesfrom the perpendicular.

The invention is further directed to processes for manufacturing anon-compliant medical balloon. In one embodiment, a thin layer of apolymeric solution is applied onto a mandrel, the mandrel having theshape of a medical balloon and being removable from the finishedproduct. High-strength inelastic fibers are applied to the thin layer ofpolymer with a first fiber layer having fibers running substantiallyalong the length of he long axis of the balloon and a second fiber layerhaving fiber running radially around the circumference of the long axissubstantially over the entire length of the long axis. The fibers arethen coated with a thin layer of a polymeric solution to form afiber/polymeric matrix. The polymers are cured and the mandrel isremoved to give the fiber-reinforced medical balloon.

In another embodiment of the invention, a polymer balloon is inflatedand is maintained in its inflated state, keeping the shape of theballoon. High-strength inelastic fibers are applied to the surface ofthe balloon, with a first fiber layer having fibers runningsubstantially along the length of the long axis of the balloon and asecond fiber layer having fiber running radially around thecircumference of the long axis substantially over the entire length ofthe long axis. The fibers are then coated with a thin layer of apolymeric solution to form a fiber/polymeric matrix. The fiber/polymericmatrix is cured to give the fiber-reinforced medical balloon, which canthen be deflated for convenience, until use.

In a presently preferred embodiment, a thin coating of an adhesive isapplied to the inflated polymer balloon or to the polymer-coated mandrelprior to applying the inelastic fibers.

DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an inflated standard medical balloon, which is usedin this invention as the base of the final composite fiber-reinforcedballoon.

FIG. 2 illustrates an inflated standard medical balloon, which is usedin this invention as the base of the final composite fiber-reinforcedballoon.

FIG. 3 illustrates the positioning of the second layer of fiber over thefirst fiber layer. The fiber is wound radially around the long axissubstantially over the entire length of the long axis of the balloon,each wrap being substantially equally spaced from the others. The fiberruns substantially perpendicular to the fibers of the first fiber layer.

FIG. 4 illustrates the positioning of the third layer of fiber over thesecond fiber layer, in accordance with another embodiment.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings, wherein like reference numbers are usedto designate like elements throughout the various views, severalembodiments of the present invention are further described. The figuresare not necessarily drawn to scale, and in some instances the drawingshave been exaggerated or simplified for illustrative purposes only. Oneof ordinary skill in the art will appreciate the many possibleapplications and variations of the present invention based on thefollowing examples of possible embodiments of the present invention.

A medical balloon in accordance with the present invention in oneembodiment begins with an inflated polymeric balloon 2, as shown in FIG.1, to which there is applied by hand or mechanically, inelastic fiber orfilament 4, as shown in FIG. 2. This is sometimes referred to as the“primary wind.” To assist in placement and retention of the fibers,there can be applied an adhesive to either the inflated balloon surfaceor to the fiber. The purpose of this first application of fiber is toprevent longitudinal extension (growth) of the completed balloon.

An alternate method of applying the longitudinal fibers involves firstcreating a fabric of longitudinal fibers by pulling taut multipleparallel fibers on a flat plate and coating with a polymeric solution tocreate a fabric. The fabric is then cut into a pattern such that it canbe wrapped around the base balloon or mandrel.

Next, a second application of inelastic fiber 6 is applied to thecircumference of the balloon, as shown in FIG. 3. This is sometimesreferred to as the “hoop wind.” The purpose of the hoop wind is toprevent or minimize distension of the completed balloon diameter duringhigh inflation pressures.

After the hoop wind is completed, the exterior of the fiber-woundinflated balloon is coated with a polymeric solution and cured to form acomposite, con-complaint fiber-reinforced medical balloon. The outerpolymeric coating of the fiber/polymeric matrix secures and bonds thefibers to the underlying inflated balloon so that movement of the fibersis restricted during deflation of the composite balloon and subsequentinflation and deflation during use of the balloon. The polymericsolution can be applied several times, if desired. The polymericsolution can use the same polymer as or a polymer different from thepolymer of the inflated polymeric balloon 2. The polymers should becompatible so that separation of the composite balloon is prevented orminimized.

In a second method of making a medical balloon of the present invention,a removable mandrel having the shape that is identical to the shape ofthe inside of the desired balloon is used. A shape such as shown in FIG.1 is suitable. The mandrel can be made of collapsible metal or polymericbladder, foams, waxes, low-melting metal alloys, and the like. Themandrel is first coated with a layer of a polymer, which is then cured.This forms the inner polymeric wall of the balloon. Next, repeating thesteps as described above, the primary wind and the hoop wind are placedover the inner polymer wall, followed by a coating with a polymericsolution and curing thereof to form a fiber/polymeric matrix outer wall.Finally, the mandrel is removed, by methods known in the art such as bymechanical action, by solvent, or by temperature change, to give thecomposite medical balloon of the invention.

In view of the high strength of the balloons of the present invention,it is possible to make balloons having a wall thickness less thanconventional or prior art balloons without sacrifice of burst strength,abrasion resistance, or puncture resistance. The balloon wall thicknesscan be less than the thickness given in the examples hereinbelow.

In addition, the fiber-reinforced balloons of the present invention arenon-compliant. That is, they are characterized by minimal axial stretchand minimal radial distention and by the ability not to expand beyond apredetermined size on pressure and to maintain substantially a profile.

Polymers and copolymers that can be used for the base balloon and/or thecovering layer of the fiber/polymeric matrix include the conventionalpolymers and copolymers used in medical balloon construction, such as,but not limited to, polyethylene, polyethylene terephthalate (PET),polycaprolactam, polyesters, polyethers, polyamides, polyurethanes,polyimides, ABS copolymers, polyester/polyether block copolymers,ionomer resins, liquid crystal polymers, and rigid rod polymers.

The high-strength fibers are chosen to be inelastic. By “inelastic,” asused herein and in the appended claims, is meant that the fibers havevery minimal elasticity or stretch. Zero elasticity or stretch isprobably unobtainable taking into account the sensitivity of modemprecision test and measurement instruments, affordable costs and otherfactors. Therefore, the term “inelastic” should be understood to meanfibers that are generally classified as inelastic but which,nevertheless, may have a detectable, but minimal elasticity or stretch.High strength inelastic fibers useful in the present invention includebut are not limited to, Kevlar, Vectran, Spectra, Dacron, Dyneema,Terlon (PBT), Zylon (PBO), Polyimide (PIM), ultra high molecular weightpolyethylene, and the like. In a presently preferred embodiment, thefibers are ribbon-like; that is, they have a flattened to a rectangularshape. The fibers of the first fiber layer may be the same as ordifferent from the fiber of the second fiber layer.

The most advantageous density of the fiber wind is determinable throughroutine experimentation by one of ordinary skill in the art given theexamples and guidelines herein. With respect to thelongitudinally-placed fibers (along the long axis of the balloon) of thefirst fiber layer, generally about 15 to 30 fibers having a fiberthickness of about 0.0005 to 0.001 inch and placed equidistant from oneanother will provide adequate strength for a standard-sized medicalballoon. With respect to the fiber of the hoop wind, or second fiberlayer, fiber having a thickness of about 0.0005 to 0.001 inch and a winddensity within the range of about 50 to 80 wraps per inch is generallyadequate. The fiber of the second fiber layer is preferably continuousand is, for a standard-sized medical balloon, about 75-100 inches long.

The longitudinally placed fibers should be generally parallel to orsubstantially parallel to the long axis of the balloon for maximumlongitudinal stability (non-stretch) of the balloon. The fibers of thehoop wind should be perpendicular to or substantially perpendicular tothe fibers placed longitudinally for maximum radial stability(non-stretch) of the balloon. This distributes the force on the balloonsurface equally and creates “pixels” of equal shape and size. In thecase where the fibers of the hoop wind are at a small acute angle (e.g.about 10 degrees or more) to the longitudinal fibers, two hoop winds (inopposite directions) can be used for minimizing radial distension. FIG.4 depicts a balloon having a second hoop wind 12.

EXAMPLES

The following examples are provided to illustrate the practice of thepresent invention, and are intended neither to define nor to limit thescope of the invention in any manner.

Example 1

An angioplasty balloon, as shown in FIG. 1, having a wall thickness of0.0008 inch is inflated to about 100 psi, and the two open ends of theballoon are closed off. The inflation pressure maintains the shape(geometry) of the balloon in an inflated profile during the constructionof the composite balloon. The balloon is a blow-molded balloon of highlyoriented polyethylene terephthalate (PET). To the inflated balloon isapplied a very thin coat of 3M-75 adhesive to hold the fiberssufficiently to prevent them from slipping out of position afterplacement on the balloon.

Kevlar® fibers are placed, by hand, along the length of the balloon asshown in FIG. 2 to provide the primary wind. Each of the fibers issubstantially equal in length to the length of the long axis of theballoon. Twenty-four fibers are used, substantially equally spaced fromeach other. The fiber used for the primary wind has a thickness of0.0006 inch.

Next, a hoop wind of Kevlar® fiber is applied radially around thecircumference of and over substantially the entire length of the longaxis of the balloon, as shown in FIG. 3. The fiber has a thickness of0.0006 inch and is applied at a wind density of 60 wraps per inch.

The fiber-wound based PET balloon is then coated with a 10% solution ofTexin® 5265 polyurethane in dimethylacetamide (DMA) and allowed to cureat room temperature. Five additional coating of the polurethane solutionare applied in about 6-hour increments, after which the pressure in theballoon is released. The resulting composite fiber-reinforced balloon isnon-compliant and exhibits superior burst strength and abrasion andpuncture resistance.

3M-75 is a tacky adhesive available from the 3M Company, Minneapolis,Minn. Kevlar® is a high strength, inelastic fiber available from theDuPont Company, Wilmington Del. Texin® 5265 is a polyurethane polymeravailable from Miles, Inc., Pittsburgh, Pa.

Example 2

The procedure of Example 1 was repeated with the exception that Vectran®fiber, having a thickness of 0.0005 inch is used in place of the Kevlar®fiber. The resulting composite balloon is axially and radiallynon-compliant at very high working pressures. The balloon has very hightensile strength and abrasion and puncture resistance.

Vectran® is a high strength fiber available from Hoechst-Celanese,Charlotte, N.C.

Example 3

A mandrel in the shape of a balloon as shown in FIG. 1 is made of awater-soluble wax. The wax mandrel is coated with a very thin layer(0.0002 inch) of Texin® 5265 polyurethane. After curing, adhesive andVectran® fibers are applied, following the procedure of Example 1. Next,several coats of Texin® 5265 polyurethane as applied in Example 1. Thewax is then exhausted by dissolving in hot water to give anon-compliant, very high strength, abrasion-resistant, compositefiber-reinforced balloon.

Example 4

The procedure of Example 3 is repeated using high strength Spectra®fiber in place of Vectran® fiber. Spectra® fiber is available fromAllied Signal, Inc., Morristown, N.J.

Example 5

The procedure of Example 1 is repeated using Ultra High Molecular WeightPolyethylene (Spectra 2000) fiber, which has been flattened on a rollmill. To the flattened fiber is applied a thin coat of a solution of1-MP Tecoflex® adhesive in a 60-40 solution of methylene chloride andmethylethylketone. The fiber is applied to the balloon as in Example 1using 30 longitudinal fibers, each substantially equal in length to thelength of the long axis of the balloon, and a hoop wind of 54 wraps perinch. The fibers are then coated with the Tecoflex® solution.

Tecoflex® is supplied by Thermedics Inc., Woburn, Mass.

Example 6

A balloon-shaped solid mandrel made of a low melting temperature metalalloy is coated with a thin layer of Texin® 5265/DMA solution (10%).Vectran® fibers are applied as in Example 1, followed by coating withTexin®/DMA. The metal mandrel is melted out using hot water. A very highstrength, abrasion-resistant, composite balloon is obtained, which isnon-compliant.

Example 7

Following the procedures of Example 6, a mandrel is coated with a verythin layer of PIM polyimide (2,2-dimethylbenzidine) in solution incyclopentanone. Polyimide fibers are applied, and the composite balloonis then completed with additional applications of the PIM solution. Themandrel is removed to give a high strength, puncture-resistant balloonhaving an extremely cohesive fiber/matrix composite wall that isresistant to delarnination.

Example 8

A balloon is constructed as in Example 7, except that the longitudinalfibers are replaced by a longitudinally oriented thin film made ofpolyimide LARC-IA film (available from IMITEC, Schenectady, N.Y.). Thefilm is cut into a mandrel-shaped pattern and applied to the mandrel,over which the polyimide hoop fibers and the PIM solution are applied.

Although the illustrative embodiment has been described in detail, itshould be understood that various changes, substitutions and alterationscan be made therein without departing from the spirit and scope of theinvention as defined by the appended claims.

1. A non-compliant medical balloon comprising: a first fiber layerincluding a first fiber; a second fiber layer over said first fiberlayer; wherein first fiber is substantially parallel to a longitudinalaxis of said non-compliant medical balloon.
 2. The non-compliant medicalballoon of claim 1, wherein said first fiber layer comprises inelasticfibers.
 3. The non-compliant medical balloon of claim 1, wherein saidfirst fiber layer comprises a plurality of parallel first fibers.
 4. Thenon-compliant medical balloon of claim 1, further comprising an adhesivelayer adhering to said first fiber layer.
 5. The non-compliant medicalballoon of claim 1, wherein said second fiber layer comprises aplurality of parallel second fibers.
 6. The non-compliant medicalballoon of claim 1, wherein the fibers of the first fiber layer and thefibers of the second fiber layer form an angle.
 7. The non-compliantmedical balloon of claim 6, wherein said angle is substantially a rightangle.
 8. The non-compliant medical balloon of claim 6, wherein saidangle does not change when the balloon changes from a deflated state toan inflated state.
 9. The non-compliant medical balloon of claim 1,further comprising a binding layer substantially coating said firstfiber layer and said second fiber layer.
 10. The non-compliant medicalballoon of claim 5, wherein said plurality of parallel second fibers aresubstantially transverse to the longitudinal axis of the balloon. 11.The non-compliant medical balloon of claim 10, wherein said bindinglayer is a polymeric coating.
 12. The non-compliant medical balloon ofclaim 11, wherein said polymeric coating is formed of a polymer.
 13. Thenon-compliant medical balloon of claim 11, wherein said polymericcoating is formed of a copolymer.
 14. The non-compliant medical balloonof claim 3, wherein said parallel first fibers each have a thickness ofabout 0.0005 inch.
 15. The non-compliant medical balloon of claim 5,wherein said parallel second fibers each have a thickness of about0.0005 inch.
 16. The non-compliant medical balloon of claim 5, whereinsaid parallel second fibers have a wind density of approximately 50wraps per inch.
 17. The non-compliant medical balloon of claim 6,wherein said angle is about ten degrees.
 18. The non-compliant medicalballoon of claim 1, further comprising a third fiber layer on saidsecond fiber layer.
 19. A balloon comprising: a first fiber; a secondfiber over said first fiber; wherein said first fiber is substantiallyparallel to a longitudinal axis of said balloon.
 20. The balloon ofclaim 19, wherein said first fiber is an inelastic fiber.
 21. Theballoon of claim 19, further comprising a plurality of first fibersparallel to said first fiber.
 22. The balloon of claim 19, furthercomprising an adhesive adhering to said first fiber.
 23. The balloon ofclaim 19, further comprising a plurality of second fibers parallel tosaid second fiber.
 24. The balloon of claim 19, wherein said first fiberand said second fiber meet at an angle.
 25. The balloon of claim 24wherein said angle is substantially a right angle.
 26. The balloon ofclaim 24, wherein said angle does not change when the balloon changesfrom a deflated state to an inflated state.
 27. The balloon of claim 19,further comprising a binding layer substantially coating said firstfiber and said second fiber.
 28. The balloon of claim 23 wherein saidplurality of parallel second fibers are substantially transverse to thelongitudinal axis of the balloon.
 29. The balloon of claim 27, whereinsaid binding layer is a polymeric coating.
 30. The balloon of claim 29,wherein said polymeric coating is formed of a polymer.
 31. The balloonof claim 29, wherein said polymeric coating is formed of a copolymer.32. The balloon of claim 19, wherein said first fiber has a thickness ofabout 0.0005 inch.
 33. The balloon of claim 19, wherein said secondfiber has a thickness of about 0.0005 inch.
 34. The balloon of claim 19,wherein said second fiber is wound around a circumference of the balloonwith a wind density of approximately 50 wraps per inch.
 35. The balloonof claim 24, wherein said angle is about ten degrees.
 36. The balloon ofclaim 19, further comprising a third fiber on said second fiber.